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Static Magnetic Therapy for Carpal Tunnel Syndrome (ATTRACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609113
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : January 16, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: Strong Magnetic Wristband Device: Weaker Magnetic Wristband Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blinded, Prospective, Randomized Trial of Static Magnetic Therapy for Carpal Tunnel Syndrome (CTS)
Study Start Date : August 2015
Actual Primary Completion Date : October 21, 2016
Actual Study Completion Date : October 21, 2016


Arm Intervention/treatment
Active Comparator: Strong Magnetic Wristband
Magnetic wristband of 1,795 Gauss strength
Device: Strong Magnetic Wristband
Placebo Comparator: Weaker Magnetic Wristband
Magnetic wristband of 5 Gauss strength.
Device: Weaker Magnetic Wristband



Primary Outcome Measures :
  1. Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ]
    Patient reported outcome measure of symptom severity and functional status. Is made of the Symptom severity scale (11 items) score 1 to 5 where lower numbers denotes better outcomes; and the Functional status scale (8 items) score 1 to 5 where lower numbers denotes better outcomes. Total score 1- 95 where lower numbers denotes better outcomes.


Secondary Outcome Measures :
  1. Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks [ Time Frame: Baseline and 6 weeks ]
    Ultrasound to assess the anatomy of the median nerve

  2. Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks [ Time Frame: Baseline and 6 weeks ]
    Ultrasound to assess the anatomy of the median nerve

  3. Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks [ Time Frame: Baseline and 6 weeks ]
    Ultrasound to assess the anatomy of the median nerve



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of mild to moderate Carpal Tunnel Syndrome by history, clinical exam and Electromyography (EMG) study.
  • ≥ 18 years

Exclusion Criteria:

  • Current use of magnets as therapy for Carpal Tunnel Syndrome
  • Known allergy to silicone
  • Unwillingness to wear wristband for 6 weeks
  • Patients who have devices that may be affected by exposure to magnets such as vagal nerve stimulator, pacemaker or insulin pump.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609113


Locations
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United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Vanessa Baute, MD Wake ForestUBMC

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02609113    
Other Study ID Numbers: CTS-MAG-22
First Posted: November 20, 2015    Key Record Dates
Results First Posted: January 16, 2018
Last Update Posted: September 10, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Wake Forest University Health Sciences:
Carpal Tunnel Syndrome
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries